MAUDE Adverse Event Report: JOHNSON AND JOHNSON / ETHICON PPHO3; HEMORRHOIDAL STAPLER

Device Problem Defective Component (2292)

Patient Problems Cyst(s) (1800); Pain (1994); Scar Tissue (2060)

Event Date 02/29/2016

Event Type  Injury  

Event Description

I had a stapled hemorrhoidopexy on (b)(6) 2016 in (b)(6) outpatient surgery.I immediately had pain after the use of the (b)(4) stapled device.The pain worsened to the point in which i had to quit my job, cash out my retirement.I had multiple er visits and saw multiple specialists over a 2 year period.I was in such agonizing pain that i not only could not sit without pain but had become suicidal due to the level of pain.By (b)(6) 2017 there was foreign material palpated inside of my rectum at the staple line and a mass was also felt near the location of the foreign material.In (b)(6) 2017 a surgeon saw a mass inside of the rectum at the staple line and found and removed staples.The pain persisted and in fact got worse.In (b)(6) 2018 i had to go all the way to (b)(6) to (b)(6) and a neurography showed a mass inside of my rectum.On (b)(6) 2018 what was thought to be a mass turned out to be an intrarectal cyst that was found at the staple line along with other scar tissue at the staple line.The cyst burst open in the operating room and was completely removed along with the area of tissue at the staple line.The doctor informed both me and cousin with multiple witnesses in the room that he does not use the ppho3 device after seeing it harm multiple other people over the years and that the stapling device is what caused this cyst to develop and if left untreated could have ruptured.The doctor along with other doctors are willing to testify in a court of law that they feel the device itself is harmful.The doctor who removed the cyst said that he does not feel the device malfunctioned or that the original surgeon used the device in error but rather the device itself is not a good device and he has personally treated numerous patients that have had complications with the device.My case is the most severe case he had ever seen in his career.Since the surgery 2 weeks ago i went from being in agonizing pain and unable to sit to having an 80 percent reduction in pain and can now sit again without pain.It is my understanding that the fda was aware of serious problems with this device which was recalled in 2007 and had another serious recall in 2012 but allowed to go back on the market after ethicon alleged to have fixed the issues.I am requesting the fda to do a more complete investigation into the harm caused by the ppho3 device.I have discovered that i am not the only one affected by this device and that the medical literature is clear that there are numerous complications from the use of the ppho3 device.I feel that the fda and ethicon have an obligation to ensure that the devices approved by them do not harm people and is especially obligated when another serious complaint comes forward resulting in a recall and then another person is seriously injured after the fda allows the products back on the market.I am asking you to do more than just send me a form letter saying you have received my complaint.

• Brand Name: PPHO3
• Type of Device: HEMORRHOIDAL STAPLER
• Manufacturer (Section D): JOHNSON AND JOHNSON / ETHICON
• MDR Report Key: 7376838
• MDR Text Key: 103928717
• Report Number: MW5076179
• Device Sequence Number: 1
• Product Code: GDW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/27/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Other; Required Intervention; Disability
• Patient Age: 47 YR
• Patient Weight: 74